Zemplar 5 microgram/ml Solution for Injection

  • Name:

    Zemplar 5 microgram/ml Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Paricalcitol

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/04/19

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Summary of Product Characteristics last updated on medicines.ie: 18/7/2018

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AbbVie Limited

AbbVie Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Chirocaine 1.25mg/ml solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Duodopa intestinal gel Active Ingredients Carbidopa Monohydrate, Levodopa
Medicine Name Forane 99.9% w/w, inhalation vapour liquid Active Ingredients Isoflurane
Medicine Name Moderiba 200mg Film-coated Tablets Active Ingredients Ribavirin
Medicine Name Moderiba 400mg Film-coated Tablets Active Ingredients Ribavirin
Medicine Name Moderiba 600mg Film-coated Tablets Active Ingredients Ribavirin
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Zemplar 1 microgram capsules, soft Active Ingredients Paricalcitol
Medicine Name Zemplar 2 micrograms capsules, soft Active Ingredients Paricalcitol
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
1 - 0 of 13 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 April 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 March 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 3 September 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 July 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to restricted prescription (C)

Updated on 17 July 2018 SmPC

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 

Description of change

SmPC was updated to reflect approval of Type IB - changes to mock-ups resulting from vial move from GSK to Avara + combining of Irish MA for vial and ampoule for Zemplar 5 micrograms/ml solution for injection.

 

The following is summary of the changes:

 

8.       Marketing Authorisation Number

The MAs was combined to the first MA in the series PA1824/005/004; PA1824/005/005 will be withdrawn.

 

10.       Date of Revision of Text

Update to July 2018.

Updated on 5 June 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 30 May 2018 SmPC

Reasons for updating

  • Other

Legal category: Product subject to restricted prescription (C)

Updated on 29 May 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SmPC for Zemplar 5mcg/ml solution for injection updated to reflect approval of V86 - Update to QRD and serialisation.

 

The following is summary of changes:

 

Section 2. Qualitative and Quantitative Composition

Minor changes to ensure consistency with the Zemplar capsule Product Information.

Section 4.1 Therapeutic indications

            Minor change to ensure consistency with the Zemplar capsule Product Information.

 

Section 4.2 Posology and method of administration

Editorial changes

Section 4.4 Special warnings and precautions for use

Minor change to ensure consistency with the Zemplar capsule Product Information.

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

Minor change to ensure consistency with the Zemplar capsule Product Information.

 

Section 4.6 Fertility, pregnancy and lactation

   Minor change to ensure consistency with the Zemplar capsule Product Information.

 

Section 4.7 Effects on ability to drive and use machines

Minor editorial changes

Section 4.8 Undesirable effects

            Minor change to ensure consistency with the Zemplar capsule Product Information

 

Section 4.9 Overdose

Correction of typos

Section 5.1 Pharmacodynamic properties

Correction of typos and editorial changes

Section 5.2 Pharmacokinetic properties

Minor editorial changes

Section 5.3 Preclinical safety data

Minor editorial changes and correction of typo

Section 6.2 Incompatibilities

            Correction of typo

 

Section 6.5 Nature and content of container

            Minor editorial changes

 

Section 10 - Date of Revision of Text

Updated to May 2018

Updated on 9 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 14 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 6.3 - Shelf life: Extension of shelf life for vial presentation only from 2 years to 3 years.$0Section 10 - Date of Revision of Text: February 2018

Updated on 14 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 14 February 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 11 April 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company


Section 4.2 - Posology and method of administration

Amend typing error in SmPC:

Suggested Dosing Guidelines

(Dose adjustments at 2 to 4 week intervals)

iPTH Level Relative to Baseline

Paricalcitol Dose Adjustment

Same or increased

Increase by 2 to 4 micrograms

Decreased by < 30%

Decreased by  ≥30%, ≤60%

Maintain

Decreased > 60%

Decrease by 2 to 4 micrograms

IPTH < 15.9 pmol/l (150 pg/mL)

Updated on 11 March 2016 SmPC

Reasons for updating

  • Change to MA holder contact details

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Ø  Update the IE MAH address:

 

Present:

Proposed:

 

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co. Dublin

 

 

 

AbbVie Limited

Citywest Business Campus

Dublin 24

Ireland

Updated on 10 March 2016 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 17 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

The changes include amendment to align with the current QRD V9 template headings and standard statements.

Additionally, a new standard statement has also been added at the end of SPC Section 4.8 and PIL Section 4, regarding the reporting of suspected adverse reactions through use of the national reporting system.

Updated on 16 November 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 September 2015 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 29 July 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to joint SPC covering all presentations

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update Section 4.4 Special warnings and precautions for use

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see section 4.5).



Update to include both vial and ampoule presentations on the one SmPC.

Updated on 23 December 2014 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Improved electronic presentation.

Updated on 15 August 2014 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In Section 1; glass ampoule has been added after Zemplar 5mcg/ml Solution for Injection

Updated on 11 August 2014 PIL

Reasons for updating

  • Change to packaging
  • Addition of information on reporting a side effect.

Updated on 18 September 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 7 has been updated with the new MAH, AbbVie Ltd.
Section 8 has been updated with the new PA number PA1824/5/4

Updated on 17 September 2013 PIL

Reasons for updating

  • Change of licence holder

Updated on 5 August 2011 PIL

Reasons for updating

  • Change to instructions about overdose

Updated on 5 August 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SPC section 4.4, 4.8 & 4.9 - updated in line with company safety information
SPC section 5.1 - updated to include 'Unlike calcitriol, paracalcitol is a selective Vitamin D receptor (VDR) activator' in line with WHO reclassification of paricalcitol from 'Vitamin D Analogs' (ATC Code: A11CC) to 'Anti-prarthyroid agents' (ATC Code: HO5BX).

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 20 August 2010 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.5, 4.6, 4.8, 4.9 & 6.2 updated in line with the QRD template. 

Updated on 13 January 2010 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 5.1 updated to change the pharmacotherapeutic group from 'Vitamin D and analogues A11CC' to 'Anti-parathyroid agents H05BX02'.

Updated on 26 June 2009 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 13 November 2008 PIL

Reasons for updating

  • Change to name of manufacturer
  • Change to date of revision

Updated on 4 February 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Updated on 22 November 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

6.3     Shelf life

 

2 years.

 

After opening, use immediately

Updated on 23 April 2007 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 April 2007 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 

4.4     Special warnings and precautions for use

Caution should be exercised if co-administering paricalcitol with ketoconazole.
 
4.5           Interaction with other medicinal products and other forms of interaction
 
Ketoconazole: The effect of multiple doses of ketaconazole administered as 200 mg, twice daily (BID) for 5 days on the pharmacokinetics of paricalcitol capsule has been studied in healthy subjects. The Cmax of paricalcitol was minimally affected, but AUC0-‡ approximately doubled in the presence of ketoconazole. The mean half-life of paricalcitol was 17.0 hours in the presence of ketoconazole as compared to 9.8 hours, when paricalcitol was administered alone (See PRECAUTIONS Section 4.4)
 
4.8         Undesirable effects
 

Body as a whole

Common

Headache

Uncommon

injection site pain, pain, asthenia, back pain, chest pain, fever, flu syndrome, infection, malaise, and sepsis

 

 

Post -Marketing Adverse Reactions

Immune system disorders, hypersensitivity.

Angioedema, laryngeal oedema and urticaria have been reported rarely.

Updated on 5 October 2006 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

4.2             Posology and method of administration

Pediatric Use

Data in pediatric patients are limited and no data for children under the age of 5 are available. See Section 5.1 for study results.

 
5.1             Pharmacodynamic properties

Paediatric clinical data: The safety and effectiveness of Zemplar were examined in a 12-week randomised, double-blind, placebo-controlled study of 29 pediatric patients, aged 5-19 years, with end-stage renal disease on hemodialysis. The six youngest Zemplar-treated patients in the study were 5 - 12 years old. The initial dose of Zemplar was 0.04 mcg/kg 3 times per week, based on baseline iPTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times a week based on baseline iPTH level of ¡Ý 500 pg/mL, respectively. The dose of Zemplar was adjusted in 0.04 mcg/kg increments based on the levels of serum iPTH, calcium, and Ca x P. 67% of the Zemplar-treated patients and 14% placebo-treated patients completed the trial. 60% of the subjects in the Zemplar group had 2 consecutive 30% decreases from baseline iPTH compared with 21% patients in the placebo group. 71% of the placebo patients were discontinued due to excessive elevations in iPTH levels. No subjects in either the Zemplar group or placebo group developed hypercalcemia. No data are available for patients under the age of 5.

Updated on 25 May 2005 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to restricted prescription (C)